(216 days)
The Intersurgical Hydro-Guard Mini Filter and Heat and Moisture Exchanger is for use at the patient and equipment connections. It is designed to reduce bacterial/viral transmissions between the patient and equipment and to reduce the loss of patient heat and humidity.
The Intersurgical Air- Guard Breathing Filter is for use at the equipment connections. It is designed to reduce bacterial/viral transmissions in order to protect oxygen concentrator machines and respiratory equipment.
Both filters are single patient use for an adult target patient population, are intended for use within breathing systems in healthcare and home environments where ventilation is required and a maximum duration of 24 hours.
Not Found
I am sorry, but based on the provided document excerpts, there is no information available regarding the acceptance criteria, study details, or performance of the described medical device. The document is a 510(k) clearance letter from the FDA, which primarily states that the device is substantially equivalent to a predicate device and can be marketed. It outlines regulatory requirements but does not include the technical study details or acceptance criteria for the device itself.
Therefore, I cannot provide the requested table and information about the acceptance criteria and the study that proves the device meets them.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).